MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

The Medical Device Coordination Group has published the MDCG 2021-23 guidance. This guidance is intended to provide assistance to notified bodies to implement requirements established by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to the quality management system certification activities of distributors and importers. Indeed, Article 16(4) requires a notified body to verify and attest that the quality management system of the distributor or importer carrying out one of the activities mentioned in Article 16(2)(a) and (b) amending the device complies with the relevant requirements. This guidance is also intended for distributors and importers who need to have their quality management system certified by a notified body.

Questions & Answers are being developed and will address the implementation of other relevant requirements for distributors and importers introduced by Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

DOWNLOAD THE GUIDANCE MDCG 2021-23